Nick Mulcahy

October 23, 2014

UPDATED October 24, 2014 // Localized and locally advanced cancer — not metastatic disease — will be the overriding focus of one of the most important cooperative clinical trial groups sponsored by the National Cancer Institute.

This likely means that paradigm-shifting clinical research in metastatic cancer treated with either radiation oncology or adjuvant therapies will rarely occur in trials run by the newly formed NRG Oncology group.

"The number one specific aim [of NRG Oncology] is to improve the lives of adult patients with localized or locally advanced cancers through the conduct of high-quality...clinical trials," said the group's co-chair, Dr Walter Curran, last month.

He is from the Winship Cancer Institute at Emory University in Atlanta, Georgia.

"We will occasionally do trials for patients with metastatic cancer" and advanced disease, Dr Curran told an audience at the annual meeting of the American Society for Radiation Oncology (ASTRO).

We will occasionally do trials for patients with metastatic cancer. Dr Walter Curran

NRG will be funding clinical trials in seven tumor sites: breast, brain, gastrointestinal, genitourinary, gynecologic, head and neck, and lung.

Dr Curran also said that another top priority of NRG Oncology is to investigate "new developments in medical technology," such as imaging and proton beam therapy, to "advance the care of patients with localized/locally advanced cancers." Metastatic disease was not mentioned at all in this case.

Cooperative groups such as NRG Oncology are important because they provide "practice-defining, paradigm-shifting research," said Dr Curran.

"Many of the trials could not be done at cancer centers [alone] or in a relationship with pharma," he added.

NRG Oncology is a major part of the National Clinical Trials Network, the NCI's new clinical trials cooperative group system.

NRG Oncology incorporates several "legacy" cooperative groups, including Radiation Therapy Oncology Group (RTOG), the National Surgical Adjuvant Breast and Bowel Project (NSABP), and the Gynecologic Oncology Group (GOG).

In an email to Medscape Medical News, Dr Curran said that NRG Oncology's emphasis on patients with localized and locally advanced cancers has its roots in the past trials of these older groups. The focus of NRG's trials "is intentional and builds on the extraordinary accomplishments of NRG's three legacy groups in these realms."

He also defended the lack of emphasis on metastatic disease research. "Any research group needs to focus on a defined number of health problems to make real progress, and cannot study all healthcare issues," he said.

NRG Oncology expects to enroll about 6000 to 7000 cancer patients per year in its trials, said Dr Curran. That is a large percentage of the 19,000 patients who are expected to enroll this year in the entire National Clinical Trials Network funded by the NCI.

"The scope of NRG Oncology's research portfolio is the largest of the new adult network groups and will enroll the largest number of patients," said Dr Curran.

The NCI's clinical trial system formerly involved 10 cooperative groups. That has now been winnowed down to five groups. These newly assembled groups, including NRG Oncology, have been crafting their missions and identities in conjunction with the NCI.

The other adult cooperative groups "intentionally have a broader portfolio of trials seeking to improve the outcome of patients with metastatic disease," Dr Curran pointed out. Their trials are available for enrollment by NRG Oncology physicians, he also said.

However, the nearly exclusive focus on the "curative setting" in NRG's clinical trials of radiation oncology and adjuvant therapies is disappointing, said Dr Heather Curry, of eviti, the oncology decision- support company in Philadelphia, Pennsylvania. "If the cooperative groups can't support palliative care research, where is it going to be done?" she wondered in an interview with Medscape Medical News.

If the cooperative groups can't support palliative care research, where is it going to be done? Dr Heather Curry

Dr Curry said that it is a "shame" that palliative care is being neglected, because its importance is "just emerging" in oncology practice and research.

Metastatic disease is already neglected in terms of funding in breast cancer, according to an advocate.

Only 7% of all breast cancer funding goes to researching metastatic disease, even though it accounts for about 30% of disease prevalence, Shirley Mertz, president of the Metastatic Breast Cancer Network, told Medscape Medical News last month.

Shorting metastatic cancer of research dollars has its roots in ignorance, suggested an American researcher in a New York Times article in 2013.

A lot of people are under the notion that metastatic work is a waste of time. Dr Danny Welch

"A lot of people are under the notion that metastatic work is a waste of time," said Dr Danny Welch, of the University of Kansas Cancer Center in Kansas City, "because all we have to do is prevent cancer in the first place. The problem is, we still don't even know what causes cancer. I’d prefer to prevent it completely, too, but to put it crassly, that's throwing a bunch of people under the bus right now."

The funding for big clinical trials in cancer is shrinking in general, said Dr Curran last month.

For the past 12 years, funding for cooperative group trials has been flat ($150 to $160 million per year), which means, in inflation-adjusted dollars, the funding has decreased, said Dr Curran. "There is a concern there will be fewer trials in general," he added.

"The trials in National Clinical Trials Network will be limited not by imagination but by resources," said Dr Curran.

However, there is one area of research that may get a boost by the new clinical trials scheme — "innovative" radiation oncology.

That's because the NRG Oncology apparatus has an addition that was not part of the old RTOG — the Center for Innovation in Radiation Oncology (CIRO).

CIRO aims to "promote innovative RT research within all NCTN" and "accelerate testing new radiation oncology innovations in NCTN," he said.

Judging by Dr Curran's presentation, proton therapy appears to be a prominent part of CIRO.

He cited two ongoing photon vs proton therapy clinical trials in lung cancer that will be folded into NRG Oncology and new or ongoing trials that the cooperative group will manage, including studies in malignant brain tumors, gastrointestinal cancers, head and neck cancer, and gynecologic cancer.


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